Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah
ClinicalTrials.gov Identifier:
NCT01515917
First received: January 18, 2012
Last updated: February 5, 2013
Last verified: January 2012
  Purpose

This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study.


Condition Intervention
Traumatic Brain Injury
Substance Abuse
Substance Dependence
Drug: Citicoline
Drug: Omega-3
Other: Rice bran oil
Other: Microcrystalline Cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Neurocognitive performance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids will improve neurocognitive performance in individuals with TBI and substance abuse/dependence.


Secondary Outcome Measures:
  • Brain changes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at Visit 1 (Day 0) and again at Visit 3 (Day 28) in order to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids result in changes to these brain indices in participants with TBI and substance abuse/dependence.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citicoline and Omega-3
At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of citicoline and omega-3 fatty acid, of which they will be instructed to take 1000 mg and 2000 mg daily, respectively. This will be done in a double-blind, randomized fashion.
Drug: Citicoline
Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 1000 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.
Other Name: Cognizin Citicoline
Drug: Omega-3
Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 2000 mg daily omega-3. These participants will receive a 14-day supply of omega-3 at visit 1 and again at visit 2, making for a 28-day administration period.
Other Name: Omegabrite
Placebo Comparator: Placebo
At visit 1 and again at visit 2, participants assigned to the placebo group will be given 14-day supplies of placebo to be taken daily throughout the study period. This will be done in a double-blind, randomized fashion.
Other: Rice bran oil
Rice bran oil will be one of two placebos administered to participants randomly assigned to the placebo arm. Rice bran oil will serve as the placebo for omega-3 fatty acids and will be orally administered daily in 500 mg doses.
Other: Microcrystalline Cellulose
Microcrystalline Cellulose will be one of two placebos administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran status
  • Age 18 to 55
  • History of TBI
  • DSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse
  • Multiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day
  • Stable on current psychotropic medication regimen for ≥ 3 months

Exclusion Criteria:

  • Non Veteran
  • Significant medical or neurological illness with the exception of TBI, which might affect cognitive function
  • Significant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease
  • Age other than 18 to 55 years old
  • History of ECT treatment
  • Estimated IQ < 70
  • Past or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder
  • Currently taking a prescribed blood thinner (i.e., Coumadin)
  • Claustrophobia
  • Metal implanted within the body
  • Pregnancy or lactation
  • Left-handedness
  • Poor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols
  • Non-native English speakers (for neurocognitive tasks)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Deborah Yurgelun-Todd, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT01515917     History of Changes
Other Study ID Numbers: IRB_53174
Study First Received: January 18, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Veterans
Traumatic Brain Injury
TBI
Substance Abuse
Substance Dependence
Veterans with traumatic brain injury (TBI)
Veterans with substance abuse or dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Brain Injuries
Wounds and Injuries
Chemically-Induced Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cytidine Diphosphate Choline
Rice bran oil
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 28, 2014